The IVDR was published on 5 May 2017 and manufacturers will need to start complying with it by May 2022 in order to be able to place their devices on the EU market. The challenge, until very recently, was that no notified body was approved to undertake conformity assessments under the new, more stringent, legislation. BSI is one of the first to achieve designation to the IVDR with both BSI Netherlands and UK Notified Bodies now being able to provide conformity assessments to the full scope of the IVDR, which includes over 80 codes.